Pelvic Pain Clinical Trial
Official title:
Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma - A Study to Measure Effect of Surgery, Analysis of Clinical Tests and Detection of Sacroiliac Instability Using RSA.
Verified date | September 2017 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pelvic girdle pain (PGP) related to pregnancy is a common reason to sick leave during
pregnancy. Low back pain and PGP affects about 50% of women during pregnancy. Most of the
women recover, however about 10% of the women still have complaints after birth. Most
patients have positive effect from conservative treatment, but unfortunately some do still
have much pain despite intensive conservative rehabilitation. Surgery has been tried on these
women with various results. Surgical treatment is controversial and there is a lack of
documentation. The investigators will operate 20 patients with arthrodesis to the sacroiliac
joint and symphysis. Radiostereometric analysis (RSA) will be used to evaluate the joint
movement in different part of the process.
Hypothesis: Severe pelvic girdle pain is caused by pelvic joint instability in some cases and
surgically fixation of the affected joints can help these women to get back to a normal life.
Status | Completed |
Enrollment | 9 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Pain in one or more pelvic joints. - Minimum 2 positive clinical tests. - High pain and disability score - Tried adequate physiotherapy without effect. Exclusion Criteria: - Known psychiatric diagnosis - Other spine pathology - CT verified ankylosis - BMI>30 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo university hospital - Ulllevaal | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Stiftelsen Helse og Rehabilitering |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oswestry Disability Index (ODI) | Oswestry Disability Index is a 10 item questionnaire comprises 10 questions about physical function. Each item has a 0-5 scale and the raw score is multiplied by 2 and the sum is the total score. Zero represents excellent physical function and 100 is more or less bedridden. This is the most used outcome measure in low back pain studies. | 12 months | |
Primary | Visual Analogue Scale (VAS) 0 to 10 | Visual Analogue Scale is a 0 -10 scale. Zero is no pain and 10 is the worst pain you can imagine. In this study the patients were asked to report the morgning and evening pain by this scale. | 12 months | |
Secondary | Healing Measured by CT | Number of participants with healing as measured by CT data. The outcome was radiological healing vs no signs of radiological healing. In order to be classified as healed the CT scans had to show Clear signs of bone bridging across the sacroiliac joint. | 12 months |
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